Clinical SDTM Programmer

This role is highly focused on SDTM oversight, standards, and submission readiness, with direct visibility across study teams and regulatory deliverables.

About the Role

As an Advanced SDTM Clinical Programmer, you will provide end‑to‑end oversight of SDTM programming activities, from study set‑up through to submission‑ready packages. You will act as a technical authority on CDISC standards, ensuring quality, compliance, and consistency across trials while collaborating closely with Data Management, Statistics, and clinical teams.

This is an ideal opportunity for someone who enjoys SDTM governance, review, and strategic input, not just hands‑on programming.

Key Responsibilities

• Provide expert oversight of SDTM programming activities from study start‑up through database lock and regulatory submission

• Lead or review the development of submission‑ready CDISC SDTM packages, including aCRFs, define.xml, and cSDRGs

• Review and contribute to trial set‑up documentation, including data transfer agreements, metadata, and trial design specifications

• Create or review SDTM mapping specifications for internal and external data sources

• Generate or oversee the creation of SDTM datasets using standardized conversion frameworks and utilities

• Ensure high-quality, compliant datasets, including Pinnacle 21 review, readiness for interim analyses, medical review, and final lock

• Program or oversee data quality checks and review reports to support Data Management and study teams

• Maintain regulatory awareness, ensuring SDTM deliverables meet FDA, PMDA, and global submission requirements

• Act as a subject matter expert across CDISC standards (SDTM, CDASH, controlled terminology, define.xml)

• Support the development and implementation of programming standards within the organisation

• At senior level: mentor junior or flexible resources and provide leadership or coordination of support teams where required

Key Interfaces

You will work closely with a wide range of stakeholders, including:

• Clinical Programmers and Statistical Programmers

• Clinical Trial and Data Management teams

• Clinical Data Standards groups

• External DM CRO partners

• Enabling Business & Information Services (EBIS)

Required Experience & Skills

• Bachelor’s degree (or higher) in Computer Science, Data Science, Mathematics, or a related scientific discipline (or equivalent experience)

• Strong clinical programming background with hands‑on trial experience

• Expert knowledge of SAS programming within a clinical research environment

• Advanced expertise in CDISC SDTM, including aCRFs, define.xml, and cSDRGs

• Deep understanding of clinical data structures (SDTM and working knowledge of ADaM)

• Experience working in global, cross‑functional clinical research teams

• Comfortable operating in a fast‑paced, matrixed FSP environment

• Strong organisational, communication, and stakeholder management skills

• Project oversight or coordination experience is highly desirable

Why Apply?

• Long‑term stability through a strategic FSP partnership

• Direct exposure to high‑impact regulatory submissions

• Opportunity to operate as an SDTM standards and oversight expert, not just a producer

• Collaborative, global environment with access to industry‑leading tools and standards

• Clear pathway for senior technical influence and mentorship